2 Organizations You Need to Join to Get Ready for the DSCSA Phase II

If you are a pharmaceutical company serious about meeting the requirements of Phase II of the DSCSA, there are two organizations you must join. 

The first is the Partnership for DSCSA Governance, or the PDG. It is an organization formed by manufacturers, wholesalers, dispensers, and solution providers that are working to solve the interoperability requirements for the DSCSA for 2023. The PDG is a 501(c)(6) nonprofit business association requiring a yearly membership fee to join. 

The other is the Healthcare Distribution Alliance, or HDA, which is a long-running organization that represents many members of the pharma supply chain in a quest to advocate for public policy that supports patient access to medical products through safe, efficient, and effective distribution. The HDA also requires a yearly membership fee.

Today’s post will look at both organizations, profile what they do, and then let you know why joining them is crucial for getting the most out of the DSCSA.

DSCSA 2023 Requirements

While we have written extensively about the DSCSA 2023 Phase 2 requirements in previous posts, we will briefly look at the DSCSA 2023 requirements to better understand why the PDG and HDA are valuable memberships for you and your company. 

The DSCSA comes in two phases. The first phase (2015 to 2023) is focused on the requirement to have tracing capabilities at the lot level. The second phase will go into effect on November 27, 2023, and take tracing one step further by calling for the interoperable electronic tracing of products at the package level.  

The adjustment to the 2015 requirements came a bit easier for companies because, at least thus far, the 2023 interoperability requirements have much less detail in the statutes concerning them. They paint a fuzzy picture of the future, which has led to anxious stakeholders within pharma. 

What we do know for certain is that there are three specific, interrelated components that Phase II brings into effect in 2023:

“Interoperable Exchange: Trading partners must exchange required transaction information (TI) and transaction statements (TS) in a secure, electronic, interoperable manner, and the TI must include the product identifier at the package level.

Interoperable Verification: Trading partners must be able to verify the product identifier on a package or sealed homogenous case in a secure, electronic, interoperable manner.

Interoperable Tracing: Trading partners must maintain secure, electronic, interoperable systems and processes to provide TI and TS in response to a request for it and to promptly facilitate gathering the information necessary to produce the TI for each transaction going back to the manufacturer.”

To help meet all three components of the DSCSA, it will take all members of the pharma supply chain industry to work together. 

This call-to-action is exactly why the PDG and HDA can help you and your firm.

Introducing the Partnership for DSCSA Governance (PDG)

According to its website, The PDG is “a collaborative forum and FDA public-private partnership dedicated to developing, advancing, and sustaining an effective and efficient model for interoperable tracing and verification of prescription pharmaceuticals in the U.S.”

The organization is an independent, balanced, and sector-neutral nonprofit that was created to support the DSCSA’s vision of 2023 interoperability and serve as a point of communication for the various stakeholders working with the FDA to implement Phase II. To make this possible, “Each trading partner will be committing significant resources to the implementation of the DSCSA 2023 requirements.”

The PDG is a hub for DSCSA communication as 2023 approaches, which is why it is a valuable member for you and your company if you haven’t already joined. Working with members from throughout the supply chain, the organization is committed to gathering and using serialized data among trading partners with the belief that this is the best way to help implement the DSCSA requirements for electronic interoperable verification and tracing. Without groups like the PDG, information silos would completely derail the implementation. 

So, to help keep the information flowing, “the formal structure of PDG, with well-understood, agreed-upon rules for governance, will provide confidence and predictability in the allocation of those resources.” The PDG acknowledges that this is still a work in process, saying, “Interoperability in 2023 and beyond will require a level of cooperation, coordination, and interconnection at the unit level not present today. Stakeholders throughout the supply chain, including FDA, have broadly recognized that governance is critical to the successful implementation of DSCSA 2023 interoperability.”

To ensure this cooperation and coordination is achievable by the Phase II deadline, the PDG is working hard to educate and inform its impressive list of members.

Work Groups Within the PDG

On top of access to information and an amplified voice in the DSCSA implementation process, the PDG is using its diverse experience and expertise to spark collaboration within four workgroups that support its Interoperability Committee:

The Credentialing and User Authentication Work Group is responsible for defining the systems and processes by which trading partners/users will demonstrate permission to request and exchange data in the governed environment, including “authorized” status.

The Serialized TI/TS Data Exchange Work Group is responsible for defining any systems and processes and business requirements and identifying messaging standards needed to enable interoperable electronic verification and tracing.

The Verification Architecture Work Group is responsible for defining systems and processes by which trading partners can implement the requirements to verify products in an interoperable, secure electronic manner.

The Tracing Architecture Work Group is responsible for defining systems and processes by which trading partners can implement the requirements to trace products in an interoperable, secure electronic manner.

Together, their outputs “are synthesized by the Interoperability Committee” and used to work toward creating and implementing a comprehensive vision for interoperability.

The PDG has set forth a very aggressive goal to achieve a fully governed model for the industry to achieve interoperability by 2023.

Timeline

December 2019 – PDG Formally Initiated 

December 2020 – Vision Framework Defined

December 2021 – Technical and Use Case Requirements Developed

December 2023 – Interoperable System

All of this work helps the organization enact its vision of enhancing pharmaceutical supply chain security in the interest of patient safety for generations to come.

Introducing the Healthcare Distribution Alliance (HDA)

The HDA, as it stands now, has a long history – nearly 150 years! 

It was founded in 1876 as the Western Wholesale Druggist’s Association and has evolved over time, taking on new names (the National Wholesale Druggists’ Association in 1882 and then the Healthcare Distribution Management Association in 2000) before finally becoming the HDA in 2016.

Despite the name changes, the company’s missions have remained constant since 1876: 

Advocate for sound public policy that supports patient access to medicines and medical products through safe, efficient, and effective distribution;

Lead the healthcare supply chain on policy issues, business practices, and industry guidelines to inform and support member development of innovative solutions; and,

Convene and partner with public and private stakeholders to facilitate discussions on industry issues, provide education and support the sharing of leading practices.

Currently, the HDA is headquartered in Arlington, Virginia, and represents an extensive amount of pharma stakeholders, including:

36 distribution companies (national, regional, and specialty)

More than 130 manufacturers 

More than 50 service provider/international members that serve more than 180,000 licensed healthcare providers

Unlike the PDG, the HDA was not created in response to the demands of the FDA’s DSCSA, but for an organization committed to “advocating for sound public policy and supporting patience access to medicines” it only makes sense that the DSCSA work is at the forefront of their activity right now since it is the hot topic in the industry. 

HDA Extended: More Value Delivered with Membership

With a diverse collection of members creating thought-provoking content, one of the major ways the HDA is supporting the movement toward DSCSA is consistently releasing high-level content either inform followers or make projections about the near future and the best course of action for the industry to take.

While membership provides the most access to the people and content, you can read these posts for free. A few particular examples to look at include:

DSCSA, the 2023 Requirements and EPCIS: This piece is a good contextual piece for a deep-dive on the DSCSA 2023 requirements, and more specifically, evaluating how the industry is doing in responding to them. It was released right after the FDA’s decision to extend the enforcement discretion related to the next major milestones, so it encourages members to embrace the postponement but also remember it is just that… a postponement. According to the article, “reaching the ultimate deadline, or ‘Enhanced Drug Distribution Security,’… will require considerable effort, resources — and based on industry experience to date — lead time.” If you’re ready to see how you should prepare, check out this post.

Davis Spotlights HDA’s 2021 Strategic Priorities: This is an update-heavy piece from President and CEO Chip Davis offering a 2021 “Pharmacy Outlook” that is related to moving toward Phase II requirements, as well as a broader look at the industry.

DSCSA Saleable Returns: Industry Plan for Best Using the Enforcement Discretion Period: This article examines the network challenges for saleable returns and the best approach for moving forward. Although it was published in late 2019, the information is still sharp and relevant. 

These are just a few examples of blogs coming from the HDA, and every article provides lots of useful information. It would be a great idea to subscribe and stay up to date.

The HDA also organizes a weekly meeting to tackle the returns saleable requirements with VRS and the 2023 interoperability requirements.

Ready to Get Involved?

Applying to join the PDG is a very simple process.  However, you do have to be accepted. If accepted,  you’ll be invited to participle in committees and groups working together to support interoperability, and you’ll have direct access to a valuable communication hub spearheading the DSCSA efforts.

If that’s not enough, here are a few more reasons to join, straight from the PDG: 

  1. There is an urgent need for DSCSA governance, and if stakeholders do not step up to fill that need, compliance will be in jeopardy.
  2. Governance participation provides an opportunity to define an efficient pathway to interoperability that accounts for your organization’s interests and needs.
  3. Participation will help your organization develop insights on achieving interoperability, including unique regulatory perspectives.
  4. Participation will solidify your organization as an industry leader.

Joining the HDA is also a simple process but it varies based on if you’re a distributor, manufacturer, service provider, or something else.  Fortunately, the organization has created a “Maximizing Your HDA Memberships webinar” that explains the process while teaching you how to use your corporate membership and get the most out of your company’s investment in the membership. 

The time to watch the webinar is worthwhile, especially considering how HDA membership will give you unprecedented access to a long-running organization that provides countless networking opportunities, research, and top-notch member-developed education. An organization that’s been around for 150 years knows a thing or two about providing value for its members, so do not wait to join — especially with DSCSA looming.

Yes, membership with both of these organizations will come at a cost, but the benefit far outweighs the price tag. If you’re ready to get your company serious about the DSCSA, then there’s no time to waste… you should join both these organizations now.

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About the Author:
Christian Souza is the Co-Founder of TrackTraceRx

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